Clinical Operations Featured Articles
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What Will Clinical Research Certification Mean To Pharma?
10/18/2016
The National Board of Medical Examiners (NBME) is a not-for-profit organization that has been around for over 100 years. Its primary mission is assessing the qualifications of healthcare professionals. More recently, the group has been looking into developing an assessment that would be helpful to clinical researchers.
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TransCelerate Seeks To Improve Clinical Trial Quality
10/12/2016
TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.
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How Nektar Therapeutics Improves The Transactional Outsourcing Model
10/3/2016
As pharma’s use of CROs continues to grow, so does the talk about outsourcing models. Today, one of the most popular models seems to be highly integrated strategic partnerships. Unfortunately, that model does not work for every company. Partnering agreements often seem to be built on a broad and sustainable pipeline, but for small- and mid-sized companies, that pipeline often does not exist.
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The High Price Of Failed Clinical Trials: Time To Rethink The Model
10/3/2016
Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.
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Clinical News Roundup: Is 80 Percent Of China's Clinical Data Fabricated?
9/30/2016
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
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How Payment Automation Can Improve Site Satisfaction
9/29/2016
I recently wrote an article that focused on the frustrations sites have with sponsors. Their greatest gripe, to no one’s surprise, is site payments. Sites receiving payments late, and receiving a check with no supporting documentation, can cause delays and frustration, especially for smaller sites that can’t float a payment for three months or longer.
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Adaptive Trials: Complex But Advantageous
9/28/2016
When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.
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Clinical News Roundup: HHS To Provide More Info To Patients
9/23/2016
Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.
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CROs Can Be Indispensable As Pharma Companies Focus On Value
9/15/2016
The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.
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3 Things You're Doing That Drive Your Sites Insane!
9/15/2016
Many pharma companies have become focused on becoming a sponsor of choice. We believe this comes from the recognition that partnerships are a two-way street. In order for the industry to conduct trials faster, more efficiently, and at a lower cost, sites and CROs need to be better partners to pharma. At the same time, however, pharma needs to be a better partner to sites and CROs. Still, many wonder what it means exactly for a sponsor to be a better partner.